Labcompliance On-line Audio Seminar

On-line Audio Seminar 148

This seminar has been recorded and is available on CD and for
instant download. All reference material as listed below and more is
available on a special seminar website. The website is regularly
updated with most recent information. In case there are questions
related to the topic, they can be submitted through a web form and
will be answered by the speaker. For ordering info click here)

Effective GxP Training Practices

What to train - How much to Train - How to
Document Effectiveness

Recorded

No or inadequate training of employees is one of most frequently cited
deviations in FDA inspection observations and warning letters. Trainings are
either not planned, not conducted, not evaluated or not documented as expected
by inspectors. On the other hand it has been is estimated that about 5%
ofemployee's time is spent for training. So there seems to be lack of
understanding on what the regulations are, their interpretations and
expectations of inspectors.

Key Questions related to trainings are:

What do FDA and other regulations say about training?

What exactly are the expectations of inspectors?

How to develop an efficient and compliant training program?

What are the most efficient tools for GxP and part 11
training?

How to develop and document training plans for employees?

Does risk based training make sense?

What documentation should be available as evidence for
successful training: are certificates enough?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. During the seminar, the speaker will
present strategies and give practical recommendations. After the
seminar, an extensive list of reference material like primers, SOPs,
templates and examples will help immediate and cost effective
implementation.

During the interactive presentation you learn about:

GxP training requirements in US and EU

Most frequently cited deviations

Developing an effective training program for a company, site
or department.

Developing a training plan for individual employees

Who can or should be responsible for the training program
and training plans.

Most efficient training tools for different tasks.

Assessment of successful participation

The benefits of risk based training

Documentation of trainings for the FDA

Specific training requirements for part 11

And for easy and instant implementation:
download 10+ documents from special seminar website

Primer: Successful compliance training

SOP: Training for GMP Compliance

SOP: Training for GxP, 21 CFR Part 11 and Computer
Validation

SOP: Training of Laboratory Personnel

Checklist: Initial and On-going Trainings

Templates: Documentation of training plans, evaluation of
trainings, training results for the US FDA and EU

SOP: FDA Inspections - Preparation, Conduct, Follow-up

Five Warning letters and Inspectional observations related
to training.

120 page primer on basics of GLP, GMP and equipment and
computer validation. An excellent training tool for beginners.

How to order

About Audio Seminars

Online audio seminars are presented over the phone. During the
live presentation attendees can:

Study the printed slide material

Watch the slides on a computer

Watch the slides on a video screen in a seminar room

Ask questions over the phone

Ask questions through web forms

Attendees can discuss and ask questions over the phone, fax or
e-mail.

The transcript and questions and answers have been be posted at the seminar
website. This includes questions that came through e-mail and life during the
seminar.

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
agencies.

Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,
click here.